A Study of NKX019 for Systemic Lupus Erythematosus
This study is testing a new cell therapy called NKX019 for people with systemic lupus erythematosus (SLE), including those with active lupus nephritis (kidney inflammation). NKX019 is a type of CAR NK cell therapy, which uses modified immune cells to target specific cells in the body. Before receiving NKX019, participants will get a drug called cyclophosphamide to prepare their immune system. The main goal of this study is to see how safe NKX019 is and if people can tolerate it. Researchers will also look at how well it works and how the body handles the treatment. You may be able to join if you are 18-65 years old and have a certain score on a lupus activity assessment (Hybrid-SLEDAI). The study aims to enroll 6 participants, but its current status is unclear.
- Study design
- This is an open-label, non-randomized Phase 1 study, meaning everyone knows what treatment they are receiving. It will involve a small group of 6 participants.
- What's involved
- You will have screening appointments, an active treatment period, and then follow-up visits every 90 days for two years to assess your disease.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for two years after treatment to monitor for any side effects.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06518668
A Study of NKX019, a CD19 CAR NK Cell Therapy, in Subjects With Systemic Lupus Erythematosus
Enrolling by Invitation
PHASE1Ages 18–65InterventionalTreatmentHospital for Special Surgery, New YorkInvestigator-initiated
~6 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:NKX019Cyclophosphamide LD
At a glance
Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events (AEs)
Measured over 2 years
Conditions
Where it's being run
2 sites across 1 statesNew York2
Study leadership
- Anca D Askanase, MD, MPH · PRINCIPAL_INVESTIGATOR · Hospital for Special Surgery, New York
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Age: 18-65 years old at the time of informed consent
Signed informed consent form, able to adhere to the study visit schedule, and comply with other requirements of the study as specified in the protocol
Score of 8 or more points on the Hybrid-SLEDAI with at least 6 points from clinical items and at least one BILAG A or 2 B
If SLE and LN: Active nephritis Class III or IV with or without Class V using the 2018 International Society of Nephrology and Renal Pathology Society (ISN/RPS) criteria as evidenced on kidney biopsy during screening or within 12 months before study enrollment. Per NIH indices, subjects must have at least activity score ≥ 2 and no more than moderate chronicity index. Subjects must have urinary protein:creatinine ratio (UPCR) ≥ 1.5 g/g or proteinuria ≥ 1.5 g/day, however, subjects must have ≤7g/ day of proteinuria.
For patients with biopsies older than 6 months we will include an adjudication committee to review clinical data and decide on appropriateness of including the patient (see section 7.3). Additionally, all patients with active LN maximally tolerated doses of renin angiotensin aldosterone system (RAAS) blockade agents, except for patients with contraindications or intolerance to RAAS.
Women of childbearing potential must have a negative serum pregnancy test at screening and agree to complete abstinence from intercourse from 2 weeks prior to administration of the first dose of study agent until 1 year after the last dose of study agents OR consistent and correct use of acceptable birth control (e.g. levonorgestrel implants, ethinyl estradiol/etonogestrel vaginal ring; injectable progesterone, intrauterine device \[IUD\] with failure rate \< 1% per year, oral contraceptives, double barrier method, transdermal contraceptive patch) OR male partner sterilization with documentation of azoospermia prior to subject's entry into the study.
Male patients must agree to always use a latex or other synthetic condom during any sexual activity with women of childbearing potential. Male participants must agree to continue to use a condom during the intervention period and for at least 1 year following last treatment with investigational product. Female partners of male participants should be advised to use a highly effective method of contraception during treatment period and at least 12 months following treatment.
One of the following: positive antinuclear antibodies (ANA) ≥ 1:80 at screening OR positive anti-dsDNA OR positive anti-Smith (anti-Sm) as determined by the local laboratory.
Refractory SLE defined as having received ≥ 2 prior therapies for SLE (one immunosuppressant and one biologic/advanced therapy) and had an inadequate response to therapy despite being on a therapeutic dose for ≥ 90 days.
For subjects taking chronic corticosteroids for SLE/LN management, the dose must be stable for ≥ 14 days before screening and cannot exceed 20 mg prednisone/day or equivalent at LD start with planned taper to ≤ 5 mg prednisone by the time of LD start with planned taper to ≤ 5 mg prednisone by the time of the first NKX019 infusion.
Negative SARS-CoV-2 test.
Exclusion
Estimated glomerular filtration rate (eGFR) as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation of \< 45 mL/min/1.73 m2 at screening.
Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period
More than 7 g/ day of proteinuria.
Previous solid organ or hematopoietic cell transplant or planned transplant within study treatment period.
Congenital or acquired immunodeficiency resulting in severe infection or those receiving chronic immunoglobulin replacement therapy.
Liver disease or dysfunction, including cirrhosis and/or aspartate aminotransferase, alanine aminotransferase, or bilirubin ≥ 3 times the upper limit of normal.
Pulmonary comorbidity including chronic obstructive pulmonary disease or asthma requiring daily oral steroids or resting hypoxemia (\< 90% oxygen saturation via pulse oximetry) on room air.
\>10 pack years of smoking.
Exacerbation of COPD/asthma requiring systemic steroid therapy within the past 6 months.
Bone marrow insufficiency unrelated to active SLE (according to Investigator judgment) with white blood cell count \< 1,500/mm3; hemoglobin levels \< 9 g/dL absolute neutrophil count (ANC) \< 1,000/mm3; absolute lymphocyte count \</=500 mm3, or platelet count ≤ 75,000/mm3
Major cardiac disease, abnormalities, or interventions as defined by, but not limited to:
Any overlapping autoimmune condition for which the condition or the treatment of the condition may affect the study assessments or outcomes (e.g. scleroderma with significant pulmonary hypertension; any condition for which additional immunosuppression is indicated). Overlapping conditions for which the condition or treatment is not expected to affect assessments or outcomes (e.g. Sjögren's syndrome) are not excluded.
Pregnancy, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions or planned oocyte and sperm donation.
Current/active infection, and any infection requiring systemic antimicrobial therapy within the past 30 days of planned LD.
History of positive HIV antibody or test positive at screening. Hepatitis B or C positive at screening, active tuberculosis (TB) or latent TB requiring suppressive therapy.
Major surgery within 28 days prior to the first dose of NKX019 or any surgery from which the subject has not recovered or has ongoing complications.
Malignancy within 5 years of screening, with the exception of basal and squamous cell carcinomas treated by complete excision. Subjects with cervical dysplasia that is cervical intraepithelial neoplasia but have been treated with conization or loop electrosurgical excision procedure, and have had a normal repeat Papanicolaou test are allowed.
Prior cellular therapy, including mesenchymal, CAR-T or CAR-NK cells.
Prior cerebrovascular ischemia/hemorrhage including transient ischemic attack within 90 days prior to the first dose of NKX019.
Any other acute or chronic medical or psychiatric condition, or known laboratory abnormality that, in the Investigator's opinion is expected to:
Prior therapies for SLE, including investigational agents, within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to lymphodepletion.
Currently taking or known need for any of the medications prohibited in the study protocol.
Known hypersensitivity or contraindications to the study treatment including LD; or other components such as human serum albumin or dimethyl sulfoxide.
What this trial measures
- Incidence of adverse events (AEs)2 years
This is to measure safety and tolerability of NKX019, administered after lymphodepletion (LD). Adverse events will be graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0, including dose-limiting toxicities (DLTs). A DLT is defined as an AE or clinically significant laboratory abnormality (laboratory abnormalities, including transient \[lasting \< 24 hours\] or isolated out of range values) occurring within 28 days from the first dose that is possibly attributable to NKX019.